Arunava Majumder
Bengaluru
Summary
- Strategic clinical operations and health-tech leader with 8+ years of extensive experience in global clinical trial operations and management, 4+ years of experience in clinical trial project management and regulatory affairs management, 2+ years of experience in agile software project management and product development, helping top-tier MNC Pharmaceutical Companies, Contract Research Organizations (CROs) and Health Technology organizations deliver large-scale Phase II, Phase III and Phase IV global clinical trials and trial software products to drive success and growth for the organizations have worked for.
- Excel in delivering high-quality clinical trials, and have a talent for global clinical trial project management, country operations management, GCP audits, and regulatory inspection readiness, KOL management, business development, medical writing, regulatory affairs management, CRA and CTA training, and fostering growth.
- Dedicated to enabling Pharmaceutical Biotechnology and Health-technology organizations to discover and implement effective solutions for complex, high-priority clinical trials.
- Expert in advancing new technologies to optimize clinical trial management, reduce costs and timelines, and enhance trial data quality, serving as a pivotal consultant.
- Possesses over 8 years of comprehensive experience in spearheading global clinical trials in various therapeutic areas, including Immuno-Oncology, Cardio-metabolic disorders, Diabetes, Gastroenterology, Neurology, Pediatrics, and Dermatology. Expertise encompasses the entire spectrum of trial phases, from early to late-stage, with a strong emphasis on leveraging data analytics for delivering high-quality clinical trials.
- Demonstrated experience in agile software project management, EDC and EHR designing, Trial Management Software Validation, Trial Software Product Development and Management (GxP standardized), and Product Implementation.
- Winner of AstraZeneca Best CRA, Welocity Enthralling Performer, and Newcomer of the Year between 2017-2021.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Associate Director and Country Lead-Clinical Trial Operations
Pi Health Ltd.
Bengaluru
11.2022 - Current
- Orchestrated the setup of phase II-IV interventional clinical trials, ensuring regulatory compliance, data integrity, trial oversight, and effective stakeholder communication, which enhanced operational efficiencies and project delivery timelines as a global study lead for BeiGene’s immuno-oncology portfolio in India.
Clinical Research Associate-Oncology
AstraZeneca
Bengaluru
03.2021 - 11.2022
- Led the management of global phase III oncology clinical trials as oncology lead CRA for AstraZeneca, delivering high-priority immuno-oncology clinical programs, as measured by successful completion of trials on time, by applying Lean Six Sigma principles to enhance project efficiency.
Clinical Research Associate-II
IQVIA (FSP Eli Lilly)
Bengaluru
08.2019 - 03.2021
- Managed Phase III global clinical trials for Eli Lilly, orchestrating collaboration between internal and external teams across Eli Lilly Indianapolis HQ and IQVIA Global Hub, UK, to oversee clinical trials in India.
Clinical Research Associate
AstraZeneca
Bengaluru
08.2017 - 08.2019
- Managed comprehensive site operations for phase III global clinical trials in Biopharmaceuticals and Oncology, collaborating with AstraZeneca's international hubs in the UK, USA, Poland, and China, which led to the streamlined execution of trial protocols and improved cross-functional team coordination.
Officer-Clinical Biostudies
Lotus Labs (unit of Teva Pharmaceuticals)
Bengaluru
12.2016 - 08.2017
- Led the E2E management of BA/BE clinical trials for Teva Pharmaceutical Industries Ltd and Actavis Pharma, directly contributing to the successful delivery of high-priority US FDA submission projects, as measured by achieving a high FDA approval rate, by streamlining trial processes and enhancing regulatory compliance.
Clinical Research Coordinator-Oncology
HealthCare Global Enterprises Ltd.
Bengaluru
05.2016 - 12.2016
- Managed phase II and III oncology clinical trials for MNC pharmaceutical sponsors, i.e. Pfizer, Roche, Celgene, AstraZeneca, Dr. Reddy's Laboratories, Sun Pharma, etc. ss a clinical study coordinator.
Education
Master of Science - Clinical Research And Management
University of Mysore
Bengaluru10-2017
Bachelor of Science - Pharmaceutical Manufacturing And Technology
Rajiv Gandhi University of Health Sciences, Karnataka
Bengaluru05-2015
Skills
- Data Visualization and Analytics: Microsoft Power BI, Excel, Spotfire
- Clinical Trial Management: Global Clinical Trial Project Management, Program Management, Clinical Study Delivery, Clinical Trial Data Analysis and Reporting, Regulatory Submissions and Reporting
- Software: MS Project, Asana, Oracle Clinical, Medidata Rave, Pi Health FICS, Veeva Systems, Figma, Jira, Salesforce, Slack, MS Office, eCOA, Canva
- Project Management: Agile, Waterfall, Lean Six Sigma, Scrum, Kanban
- Soft Skills: Exceptional presentation abilities, adept in creative problem-solving, proficient in teamwork dynamics, highly adaptable to changing environments, advanced analytical thinking capabilities, effective in cross-cultural communication, possess strong interpersonal skills, meticulous attention to detail, skilled in conflict management, proficient in contingency planning and risk management, expert in building and sustaining professional relationships, and maintains a client-focused approach
- Strategic leadership
- Coaching and Mentoring
- Operations Management
Certification
- Agile Project Management Professional - Google
- Fundamentals of Machine Learning for Healthcare- Stanford University
- Data Analytics Professional- Google
Personal Information
Title: Associate Director and Country Lead- Clinical Trial Operations
Languages
- English [Native]
- Hindi [Native]
- Bengali [Native]
Languages
English
First Language
Timeline
Associate Director and Country Lead-Clinical Trial Operations
Pi Health Ltd.
11.2022 - Current
Clinical Research Associate-Oncology
AstraZeneca
03.2021 - 11.2022
Clinical Research Associate-II
IQVIA (FSP Eli Lilly)
08.2019 - 03.2021
Clinical Research Associate
AstraZeneca
08.2017 - 08.2019
Officer-Clinical Biostudies
Lotus Labs (unit of Teva Pharmaceuticals)
12.2016 - 08.2017
Clinical Research Coordinator-Oncology
HealthCare Global Enterprises Ltd.
05.2016 - 12.2016
Master of Science - Clinical Research And Management
University of Mysore
Bachelor of Science - Pharmaceutical Manufacturing And Technology
Rajiv Gandhi University of Health Sciences, Karnataka
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